Home / Recalls / Amneal Pharmaceuticals / D-0610-2018

D-0610-2018 Class II Terminated

Recalled by Amneal Pharmaceuticals — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
April 4, 2018
Initiation Date
December 15, 2017
Termination Date
August 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,584 vials

Product Description

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Reason for Recall

Presence of particulate matter

Distribution Pattern

U.S.A Nationwide

Code Information

Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018

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